FDA approves Lilly’s plaque psoriasis drug Taltz
pharmafile | March 23, 2016 | News story | Research and Development, Sales and Marketing | Eli Lilly, Enbrel, Taltz, plaque psoriasis
The US Food and Drug Administration (FDA) has approved Eli Lilly’s Taltz (ixekizumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Taltz, administered via injection, is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.
The FDA greenlighted the drug based on Phase III trial data from more than 3,800 patients in 21 countries. The three-trial programme compared Taltz to placebo, and two of the trials compared Lilly’s drug to Amgen’s Enbrel (etanercept).
Lilly’s data suggests Taltz was superior to Enbrel on both scales used to measure skin clearance levels, including PASI 75 and sPGA 0 or 1, at 12 weeks. For comparison, the respective response rates for Taltz versus Enbrel were 87% v 41% for PASI 75 and 73% v 27% for sPGA 0 or 1.
Taltz was however associated with a marginally higher rate of infection, including upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections, compared to placebo, at 27% v 23%.
Psoriasis affects approximately 7.5 million Americans, approximately 20% are classed as having a moderate-to-severe form. Plaque psoriasis is the most common form of the condition and appears as raised, red patches of skin covered with a silvery, white build-up of dead skin cells, which are often painful or itchy.
“Many people living with psoriasis are still looking for a treatment that will successfully manage the magnitude of this disease,” says Alex Azar, president, Lilly USA, LLC. “With the approval of Taltz, we are proud to provide patients with a new treatment that may help patients experience virtually or completely clear skin.”
UNCOVER-2 and UNCOVER-3, the rate of serious adverse events during the controlled induction period (weeks 0-12) was 0.7 percent for U.S.-approved etanercept and 2 percent for Taltz, and the rate of discontinuation from adverse events was 0.7 percent for U.S.-approved etanercept and 2 percent for Taltz. The incidence of infections was 18 percent for U.S.-approved etanercept and 26 percent for Taltz. The rate of serious infections was 0.3 percent for both U.S.-approved etanercept and Taltz.
“Complete clearance of skin plaques is an important treatment goal for psoriasis,” said Craig Leonardi, M.D., lead study author and clinical professor of dermatology at St. Louis University School of Medicine. “With Taltz, physicians now have a choice that can help patients achieve virtually clear or completely clear skin; in fact, four out of 10 achieved completely clear skin. With these study results, physicians can reassure patients that consistent results can be maintained with Taltz.”
Lilly said it would launch Taltz in the US in the second quarter of 2016.
Joel Levy
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